Sr Manager, Process Quality

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Senior Manager, Quality & Compliance

LIVE

What you will do

Let’s do this. Let’s change the world. In this vital role, you will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ). As the Senior Manager, Quality & Compliance, you will play a crucial part in our mission, providing proactive end-to-end quality support for developing and implementing a risk-based quality assurance strategy for the clinical development program.

The R&D Process Quality team supports the Quality Management System (QMS) across all Amgen research areas, including discovery through the clinical development lifecycle. This team ensures that all Amgen’s business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgen’s R&D Business Process Network develops and manages fit-for-purpose standards (SOPs) that are continuously improved upon using quality by design (QbD) and risk management methods, including QMS analytics showing quality signals and trends.

Responsibilities

• Supports Amgen’s procedural framework so that all procedures maintain compliance with relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity.

• Serve as a GCP Subject Matter Expert, providing independent and objective quality advice supporting business procedures managed by Business Process Owners (BPOs).

• Maintain Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators (KPIs)

• Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network to enable Management Reviews (periodic review by management to ensure QMS health is maintained).

• Ensures our CI efforts maintain a quality culture throughout the R & D and GDO organizations.

• Ensures that all procedures are written clearly for driving Amgen’s research tasks within a diverse, complex, cross-functional team of researchers and a rapidly evolving worldwide regulatory framework.

• Partner with the Business Process Owner network by ensuring risk-based improvements to procedures to ensure that they are simple, efficient, and fit for purpose while maintaining regulatory compliance.

• Applies risk methodologies to selectively audit business processes across the R&D network that will ensure improvements to procedures through robust root cause analysis and CAPA aimed at improving procedures.

• Applies industry standard methodologies for optimal (standardized and lean) procedural documentation and the use of technology to drive an efficient and effective knowledge management system.

• Collaborates with other quality professionals within R&D to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA).

• Supports a robust regulatory intelligence system by monitoring changing regulations and ensuring that the BPO network incorporates changes efficiently and timely.

Win

What we expect of you

We are different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills and has these qualifications:

Basic Qualifications:

• Doctorate degree and 2 years of quality experience OR

• Master’s degree and 6 years of quality experience OR

• Bachelor’s degree and 8 quality experience OR

• Associate’s degree and 10 years of quality experience OR

• High school diploma / GED and 12 years of quality experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required techn